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Mapping Pathways is a multi-national project to develop and nurture a research-driven, community-led global understanding of the emerging evidence base around the adoption of antiretroviral-based prevention strategies to end the HIV/AIDS epidemic. The evidence base is more than results from clinical trials - it must include stakeholder and community perspectives as well.

16 March 2012

An Outlook on What to Expect for the Future of HIV Treatment

2012 promises a number of changes and advances in the way we treat and prevent HIV infection. There is growing enthusiasm for widespread use of antiretroviral therapy (ART), regardless of CD4 count, both for treatment and prevention. New drugs and co-formulations are coming this year that will expand treatment options and simplify drug regimens, especially for initial therapy. At the same time, political and economic realities may prevent us from being able to implement broad-scale treatment and prevention efforts, and the coming of generic drugs, while cost-saving, may put limits on our choices of antiretroviral drugs.

When to Start

San Francisco and New York City now recommend ART for everyone with HIV, regardless of CD4 count and viral load. Current U.S. treatment guidelines already come close to that aggressive standard. They recommend ART for anyone with a CD4 count below 500, and say that everyone else should consider treatment. Treatment is also recommended at any CD4 count for people with additional conditions, including pregnancy, HIV-associated nephropathy (HIVAN), hepatitis B or C, older age, high viral load, rapid CD4 decline, and high risk for heart disease.

In the minds of many HIV experts, ART is now the "default" -- recommended unless there's a good reason not to treat. Reasons why not to treat? People who aren't ready or willing to start should wait until they are. Some people have no way to pay for treatment, an increasingly common scenario even in the United States. We don't know what to do with "elite controllers" -- people whose viral loads are already undetectable without therapy. Assuming normal and stable CD4 counts, it would be hard to show a benefit to starting ART in those individuals.

How did we get to this point, where ART is recommended for virtually everyone else? First, we're recognizing that HIV isn't just a disease of immunosuppression due to CD4 decline. Untreated HIV has consequences even for people with high CD4 counts, due to the inflammation and immune activation caused by ongoing replication of the virus. Shutting off viral replication may help to reduce the long-term risk of conditions such as heart disease, cognitive decline, loss of bone density, and malignancies by reducing HIV-associated inflammation.

We also know that treating people with HIV lowers their risk of infecting others. In fact, the HPTN 052 study demonstrated that ART was 96% effective at preventing transmission to negative partners, a far greater efficacy than we've seen with any other form of prevention so far, including condoms, circumcision, microbicides, vaccines -- probably even "abstinence." Put simply, if everyone with HIV were on treatment with an undetectable viral load, we would see virtually no new cases.

Evidence of the benefit of early ART is clear, but the decision to treat early must also consider the cost of therapy, in order to weigh the costs against the benefits. Once-daily regimens are now the norm; a growing number of single-tablet regimens (STRs) are becoming available; tolerability and safety are high. Weighing the financial cost against the benefits is more complicated, since it involves economics and politics rather than science. This is where the prevention benefits of ART become so important. Some people may be unwilling to pay for universal ART for individuals, but if universal treatment can slow or even stop the epidemic, perhaps they'll see it as money well spent. (At least, that's what they should be thinking!)

Mapping Pathways by Email

The evidence base is more than P-values and confidence intervals

There is a clear and pressing need to engage policymakers and community stakeholders in the consideration of treatment and prevention options for HIV/AIDS.

This necessity has grown stronger in light of current research showing extraordinary promise of using antiretroviral (ARV) therapies for the prevention of HIV. These ARV-based strategies include a ‘treatment as prevention’ model known as TLC+ (testing, linkage to care, plus treatment) as well as vaginal and rectal microbicides and pre-exposure prophylaxis (PrEP).

Mapping Pathways includes a thorough review of the social, economic and clinical impacts of treatment as prevention and TLC+, as well as microbicides, PrEP, and post-exposure prophylaxis, in the contexts of South Africa, India and the United States. Participation and engagement is at the heart of the study, and stakeholder input across the community, research, policy and governmental spheres will be a core focus in all three countries.

The project’s aim is to provide the research and analysis that communities and policymakers need in order to formulate coherent, evidence-based decisions for HIV/AIDS treatment and prevention strategies in the 21st century.

Mapping Pathways firmly believes that the evidence base is comprised of more than scientific data derived from clinical research – it is more than P-values and confidence intervals. The perspectives, experiences, and collective wisdom of community members and key stakeholders must be valued as much as statistically significant trial results.